Analyzing Biomarkers in Drug Development
Biomarkers as indicators of biological and pathogenic processes have been used for decades to diagnose patients and prescribe treatment. In the past 10 years, however, they’ve substantially changed drug development practices. The demand for analyzing biomarkers in drug development has increased dramatically with the advancement of precision medicine. In the drug development context, biomarkers that are indicative of mechanism of action, target engagement, and clinical outcomes have been employed to assess both the safety and efficacy of an intervention. More specifically, biomarkers have been used either to select patients for clinical trials, to make go/no-go decisions, to support registration and label claims, or to treat patients.
Stability Study for EMLA Cream Using In Vitro Percutaneous Absorption “IVPT”
EMLA Cream (lidocaine 2.5% and prilocaine 2.5%) is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine. It is a numbing cream that can be placed on skin to provide pain relief. It is often used to numb an area before placing an IV, drawing blood, or giving injections.
Typical stability study is conducted by the assay of active pharmaceutical ingredient (API) in the drug product. However, the assay results may not indicate drug product’s penetration rate similarity between different products over a certain period of time frame because of the differences in its topical product qualities (such as rheology, particle size, excipients, penetration enhancers, etc.). Therefore, it is important to evaluate the penetration of compounds into human skin during drug product stability study.
In vitro human cadaver skin model using Franz diffusion cells (invented in 1975) is widely regarded as the most valid in vitro model for evaluating the penetration of compounds into human skin. It can be used to determine the product equivalence.
Validating The Simoa Technology
Most of the advanced instruments used in bioanalysis—such as Gas Chromatography (GC), High Performance Liquid Chromatography (HPLC), and Liquid Chromatography-Mass Spectrometry (LC-MS) for example—are automated. Thus, they are controlled by complex computer systems, and the information they generate is stored electronically. If these systems are to be used in regulated research studies in the US, EU, and Japan, the instruments themselves must be qualified and their supporting software and processes must be validated as meeting regulatory requirements.
Bioanalytical Small Molecule
Frontage’s experienced staff and state-of-the-art instrumentation delivers data you can trust. Count on Frontage Laboratories for reliability. From method development or transfer and validation to sample analysis and reporting, Frontage’s bioanalytical team has earned a reputation for consistent and high-quality delivery, project after project. Our bioanalytical expertise extends to combined small and large molecules such as protein, antibody, antibody drug conjugates as well as biomarker analysis for small molecule drug candidates.
CMC Product Development
Frontage’s CMC portfolio of services spans drug product development, analysis, delivery and supply, from proof-of-concept, preclinical stages through Phase III clinical trials and commercialization support. With proven success in developing drug products for novel, generic and consumer products, we focus our efforts on clients’ specific needs. Our formulation development experience and capabilities cover a wide range of dosage forms at IND, NDA, ANDA and 505(b)(2) project stages and applications.
Bioanalytical Large Molecule
Gain access to comprehensive biologics services in support of advanced development programs with Frontage’s bioanalytical laboratory. We have the capabilities to analyze virtually any peptide, protein or antibody, and have built a reputation for solving technical challenges related to assay development and validation.